Drugs
FDA has issued Acadia Pharmaceuticals a second complete response letter on its supplemental NDA for Nuplazid (pimavanserin) for treating hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP). The letter recommended the company conduct an additional trial in ADP. “While the FDA stated that Study 019 demonstrated a statistically
Drugs
Merck says it will file a response in the first half of 2023 to an FDA complete response letter it received in January on an NDA for gefapixant, an orally administered selective P2X3 receptor antagonist for treating refractory chronic cough or unexplained chronic cough in adults. The company says it
FDA Policy/General
Principal deputy commissioner Janet Woodcock says that the Congressional stalemate over advancing the user fee reauthorization package will likely damage ongoing recruitment efforts to bring onboard over 600 new staff for the next five-year user fee period. Asked about this during an Alliance for a Stronger FDA 8/4
Devices
CDRH is soliciting proposals for medical device site visits that can be accommodated in person or virtually as part of its Experiential Learning Program. In addition, the Center encourages proposals addressing patient engagement as a supplemental topic to the current observance of operations in the areas of research, device development,
Drugs
Regenxbio says it will file a BLA with FDA using the accelerated approval pathway for its RGX-121 to treat mucopolysaccharidosis type 2, also known as Hunter Syndrome. The company says its pivotal trial for RGX-121 is active and enrolling patients. Regenxbio describes RGX-121 as an investigational, one-
Drugs
FDA has issued a Form FDA 483 to Aurobindo Pharma that cites three observations after investigators inspected (7/25 to 8/2) the firm’s Unit XI, an active pharmaceutical ingredient manufacturing facility in Pydibhimavaram, a district of Andhra Pradesh, India. “At the end of the inspection, we have been
Drugs
The 7th Circuit Court of Appeals has affirmed the decision of an Illinois federal court to dismiss a suit alleging that AbbVie violated the Sherman Antitrust Act when it obtained 132 additional patents for its Humira following the 2016 expiration of the biologic’s primary patent. The suit was brought
FDA Policy/General
Federal Register notice: FDA is seeking comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 10 drug substances. The comments will be considered in preparing a response from the U.S. to the World Health Organization regarding the abuse
FDA Policy/General
After decades of high-level neglect, FDA is at last modernizing its multiple, decentralized information technology (IT) systems. Principal deputy commissioner Janet Woodcock 8/4 told an Alliance for a Stronger FDA Webcast that the agency is now working toward transformational new efficiencies through an FDA-wide enterprise approach to
Drugs
Former CDER combination products team leader Jay Jariwala has joined Sidley as senior director, regulatory compliance, in the firm’s food, drug, and medical device compliance and enforcement practice. The Sidley announcement says Jariwala worked in CDER, CDRH, and the Office of the Commissioner. He also was the assistant country
Drugs
Merck and Eisai say the Phase 3 LEAP-002 trial investigating Merck’s Keytruda (pembrolizumab) and Eisai’s Lenvima (lenvatinib) versus Lenvima as monotherapy in patients with unresectable hepatocellular carcinoma did not meet the dual primary endpoints of overall survival and progression-free survival. The combination is currently approved by
Drugs
Some 99 organizations that represent patients with rare diseases and other acute or chronic health conditions are urging congressional leadership to “resume negotiations to develop a comprehensive FDA user fee package.” In an 8/1 letter, the organizations say they are “deeply concerned about the impact that a delay in
Drugs
Pfizer says it is discontinuing the development of PF-07265803 in patients with symptomatic dilated cardiomyopathy (DCM) after an interim futility analysis of the global Phase 3 trial REALM-DCM indicated that it is unlikely to meet the primary endpoint upon completion. The trial was designed to evaluate the investigational
FDA Policy/General
Federal Register notice: FDA is making available additional draft and revised draft product-specific guidances. The documents provide product-specific recommendations on the design of bioequivalence studies to support ANDA, among other recommendations. To view the notice, click here.
Devices
Charles River Laboratories is petitioning FDA to change its regulation of endotoxic contamination assays, including licensure of all such assays, to include those that are currently unlicensed. The Charles River 8/1 petition says that for the past 50 years, the leading assays used to detect possible endotoxic contamination in
Devices
Attorney and data scientist Bradley Thompson (Epstein Becker Green) says his review of data on breakthrough device designation for 510(k)s indicates the process is not likely to be helpful for those devices. Writing in his firm’s Health Law Advisor, Thompson says that when he works with medical
Devices
CDRH director Jeffrey Shuren says that with the Environmental Protection Agency poised to propose an air pollution rule later this year to address emissions of ethylene oxide (EtO) at commercial sterilizers, FDA is working with the industry on steps to reduce emissions and also to maintain sufficient sterilizing capacity. In
Devices
FDA has approved Allergan Aesthetics’ Juvéderm Volux XC for improving jawline definition in adults over the age of 21 with moderate to severe loss of jawline definition. The approval was based on data from the company’s pivotal clinical study that showed Juvéderm effective at improving jawline definition (69.9%
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies.” The document provides instructions for the electronic submission of expedited individual case safety reports from IND-exempt bioavailability/bioequivalence studies through the FDA Adverse Event Reporting System
Drugs
FDA has approved Coherus’ Cimerli (ranibizumab-eqrn) as the only interchangeable biosimilar to Genentech’s Lucentis for all five indications, with 12 months of interchangeability exclusivity. Coherus says Cimerli belongs to the anti-VEGF therapy class of biologics that has been “revolutionary” in helping retinal patients maintain or gain vision.
FDA Policy/General
At least 2,700 ex-FDAers now work in the drug industry, while another 1,100 have come into the agency from industry. That’s the analysis developed by Grid based on information available from the Linkedin social media app. Grid says it looked into the FDA/industry revolving door
Drugs
Alnylam Pharmaceuticals says it is planning an NDA submission late this year for patisiran, indicated for treating transthyretin-mediated amyloidosis with cardiomyopathy after reporting positive data from the APOLLO-B Phase 3 study. The study met the primary endpoint of change from baseline in the Six-Minute Walk Test at